Duns Number:967279910
Device Description: One-piece Multi-unit Straight Abutment for CONELOG, Ø3.8/4.3 x 2mm (GH)
Catalog Number
-
Brand Name
BioHorizons
Version/Model Number
BC2254.4320
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K203252
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
33eb33c5-abb6-4ef7-a75f-4bbcac196ca7
Public Version Date
September 15, 2022
Public Version Number
1
DI Record Publish Date
September 07, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 569 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 982 |